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The NovaLine SP-C35 Transducer Protector is a single-use, disposable, prescription device intended for use as a protective device for pressure monitors and to help prevent contamination of the fluid pathway in hemodialysis delivery systems.

The NovaLine SP-C35 Transducer Protector consists of a plastic housing that contains a hydrophobic filter with a reference pore size of 0.2 µ m. The housing has male and female luer lock connectors that allow its attachment between a blood tubing set and the pressure monitor on a hemodialysis machine.

The NovaLine SP-C35 Transducer Protector is to be used as protective device for pressure monitors as well as to help maintain the sterility of the blood tubing fluid pathway. The 0.2 ↓ m hydrophobic filter helps prevent cross-contamination by viruses, bacterial and particulate matter while preventing the flow of fluids to the hemodialysis machine pressure monitor.

The devices are packaged sterile and labeled for single use only.

The proposed devices are provided in sterile condition, it is subject to e-beam radiation sterilization prior to release to achieve a Sterility Assurance Level (SAL) of 10-6.

Here's a breakdown of the acceptance criteria and study information for the NovaLine SP-C35 Transducer Protector based on the provided FDA 510(k) summary.

Note: This document describes a medical device, not an AI or software-based medical device. Therefore, many of the requested fields related to AI performance, ground truth, and expert evaluation are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Device: NovaLine SP-C35 Transducer Protector

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each test within the finished product performance, packaging, or shelf-life evaluations. It mentions "proposed devices" were tested, implying a statistical sample was used according to the relevant standards, but the specific number is not provided.

Data Provenance: The tests were conducted by Bain Medical Equipment (Guangzhou) Co., Ltd. in China. The data is retrospective in the sense that the testing was performed on manufactured devices to support the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not Applicable. This is a medical device (transducer protector) and not an AI/software device. The "ground truth" here refers to the physical and biological properties of the device, established through standardized laboratory testing, not human expert interpretation of data.

4. Adjudication Method for the Test Set

Not Applicable. As this is not an AI/software device involving human interpretation, there is no adjudication method in the traditional sense. Device performance is determined by objective, measurable laboratory tests against pre-defined specifications and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for imaging or diagnostic AI, comparing human readers with and without AI assistance. This device is a component of a hemodialysis system, and its performance is assessed through physical, chemical, and biological testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This device is hardware, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Standardized Test Results: Objective measurements from various laboratory tests (e.g., dimensional measurements, sterile barrier integrity, biocompatibility assays).
• Compliance with Recognized Standards: Adherence to international and national standards such as ISO 80369-7, ISO 10993 series, ASTM F88, ASTM F1929, ASTM D4169, USP , ASTM F1671, etc.
• Predicate Device Equivalence: Direct comparison to the performance characteristics of a legally marketed predicate device (Nipro Transducer Protector TP-SURE, K072988) where applicable.

8. The Sample Size for the Training Set

Not Applicable. This is a physical medical device, not an AI/machine learning model, so there is no training set.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. See response to #8.

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The DORA Disposable A.V. Fistula Needle Sets (Safety Needle Series) are sterile medical devices intended to be used as vein puncture for hemodialysis treatment. Protective Shield is used for protecting from needlestick imiury.

The DORA Disposable A.V. Fistula Needle Sets are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment.

The DORA Disposable A.V. Fistula Needle Series) are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment. Scab Remover is used for remove the scab at puncture position.

The proposed device, DORA Disposable A.V. Fistula Needle Sets, is a non-implantable blood access device, which mainly consists of flexible tube and sharp needle. It is available in three types, 1) Needle sets with safety feature, 2) Needle sets without safety feature and 3 > Dull Needle sets. Both the three types of proposed device are provided sterile and are for single use only.

The three types of proposed devices are offered in difference configurations with options that include needle gauge, needle length, wing types (fixed wing or rotatable wing).

The proposed device and its package are designed to be provided in Ebeam sterilization. The package could maintain the sterility of the device for three years.

The Protective Shield for injury prevention requires physical action by the clinician to activate and is designed to cover the cannula after treatment. Correct use of this safety feature will eliminate accidental needlestick injuries.

I am unable to provide a comprehensive answer to your request because the provided text describes a medical device, specifically DORA Disposable A.V. Fistula Needle Sets, which is an in vitro diagnostic (IVD). My capabilities are focused on analyzing documentation related to Artificial Intelligence/Machine Learning (AI/ML) based medical devices, particularly those that involve diagnostic algorithms or image analysis.

The document you provided is a 510(k) summary for a physical medical device and does not contain information about an AI/ML component. Therefore, the details requested in your prompt (e.g., acceptance criteria for an algorithm, sample sizes for test/training sets, ground truth establishment for AI/ML performance, MRMC studies) are not applicable to the content provided.

If you have a document pertaining to an AI/ML-based medical device, I would be happy to analyze it according to the criteria you've outlined.

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The NovaLine Tubing Sets for Hemodialysis - Models BL 11 and BL 12 - are sterile, single-use arterial and venous blood lines for exclusive use with the Baxter Healthcare AK98 Hemodialysis System. The blood lines serve as the extracorporeal blood circuit in patients undergoing hemodialysis treatment, by which blood is transported from the patient through a hemodialyzer and back to the patient. The pump line interfaces with a pump rotor mechanism of the hemodialysis machine which drives the flow of blood through the circuit.

The proposed devices, NovaLine Tubing Sets for Hemodialysis, mainly consists of two tubes, which are arterial line with certain components in red and venous line with certain components in blue, as well as accessory which is recirculating connector. There are two models BL 11 and BL 12, The main difference between BL 11 and BL 12 is the Drip chamber on the arterial line. There is drip chamber on the arterial line of BL 12, there is no drip chamber on the arterial line of BL 11. The BL 12 has more drip chambers than the BL 11 on the whole tubing. The proposed devices are provided in sterile condition, it is subject to e-beam radiation sterilization prior to release to achieve a Sterility Assurance Level (SAL) of 10-6.

This document does not describe an AI/ML device or its performance criteria. Instead, it is a 510(k) summary for a NovaLine Tubing Sets for Hemodialysis, a medical device used in hemodialysis treatments.

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/ML device as none are present in the provided text.

The document discusses substantial equivalence for a medical tubing set based on:

• Non-clinical tests: Verification against design specifications and compliance with standards such as ISO 8638, ISO 594-2, ASTM D4169-16, ASTM F88/F88M-15, and ASTM F1929-15.
• Biocompatibility: Conformance to ISO 10993 series standards, with the patient contact materials of the proposed device being covered by those of the predicate device.
• Sterilization: Achieves a Sterility Assurance Level (SAL) of 10-6.
• Physical performance: Comparison of tube lengths, priming volume, positive/negative pressure, and blood flow rate limitations against the predicate device, noting that both comply with relevant ISO standards.

No clinical study was included in this submission.

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The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.

The Surgical Masks are single use, three-layer, flat-pleated masks with ear loops and nose clip. The inner and outer layers of the mask are made of spunbond polypropylene, and the middle layer is made of meltblown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the mask by ultrasound. The ear loops are made of polyester and spandex. The nose clip is made of polyethylene and galvanized iron wire. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The size of the proposed device is 17.5cm×9.5cm. The proposed device is a Level 2 mask based on ASTM F2100-2019. The Surgical Masks are blue and provided non-sterile.

This document describes the performance testing for the Bain Medical Equipment (Guangzhou) Co., Ltd. Surgical Masks (K203524).

1. Table of Acceptance Criteria and Reported Device Performance

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The DORA Disposable A.V. Fistula Needle Sets (Safety Needle Series) are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment. Protective Shield aids in the prevention of accidental needlesticks.

The DORA Disposable A.V. Fistula Needle Sets are single-use sterile medical devices intended to be used as vein puncture for hemodialysis treatment.

The proposed device, DORA Disposable A.V. Fistula Needle Sets, is a non-implantable blood access device, which mainly consists of an adaptor, flexible tube and sharp needle. It is available in two types, 1) Needle sets with safety feature and 2) Needle sets without safety feature. Both the two types of proposed device are provided sterile and are for single use only.

The two types of proposed devices are offered in difference configurations with options that include needle gauge, needle length, wing types (fixed wing or rotatable wing).

The proposed device and its package are designed to be provided in Gamma sterilization. The package could maintain the sterility of the device for three years.

The Protective Shield for injury prevention requires physical action by the clinician to activate and is designed to cover the cannula after treatment. Correct use of this safety feature will eliminate accidental needlestick injuries.

The proposed device is used in conjunction with following hemodialysis blood tubing sets during clincial use.

The provided document, a 510(k) Summary for the DORA Disposable A.V. Fistula Needle Sets, details the premarket notification of intent to market the device and its substantial equivalence to a legally marketed predicate device. This type of submission focuses on demonstrating that a new device is as safe and effective as an already approved device, rather than proving novel effectiveness through extensive clinical trials.

As such, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria in the context of:

• A table of acceptance criteria and reported device performance for an AI/ML or diagnostic device. This document is for a physical medical device (AV fistula needle sets).
• Sample sizes for a test set (for AI/ML validation). The testing described is for physical characteristics and biocompatibility, not for a 'test set' in the AI/ML sense.
• Data provenance for a test set (for AI/ML validation). Not applicable to a physical medical device.
• Number of experts and their qualifications for establishing ground truth. Not applicable.
• Adjudication method for a test set. Not applicable.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Not applicable.
• Standalone (algorithm only) performance. Not applicable.
• Type of ground truth used (expert consensus, pathology, outcomes data). Not applicable.
• Sample size for training set. Not applicable.
• How ground truth for training set was established. Not applicable.

Instead, the document focuses on non-clinical testing and substantial equivalence to a predicate device.

Here's what the document does provide regarding acceptance criteria and performance:

1. Acceptance Criteria (via Standards Compliance and Performance Testing) and Reported Device Performance:

The acceptance criteria for this device are demonstrated through adherence to various international and national standards, as well as the successful completion of specific non-clinical performance tests. The reported performance is that the device "met all design specifications" and "is similar as that of the predicate device" or "acceptable."

2. Sample sizes used for the test set and the data provenance:

• Sample Sizes: Not explicitly stated with specific numbers (e.g., "n=X needles were tested"). The document generally states "Non clinical tests were conducted" and "The test results demonstrated...". For a 510(k) submission for a physical device, detailed sample sizes for each specific test are typically found in the full technical documentation, not summarized in the 510(k) summary as it is here.
• Data Provenance: The tests were conducted internally by Bain Medical Equipment (Guangzhou) Co., Ltd. or by test labs they contracted. The document implicitly indicates the tests originate from China (Guangzhou) as that's the manufacturer's location. The tests are "non-clinical" and likely conducted in laboratory settings, not on patient data or retrospective/prospective human studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as this is a physical medical device. "Ground truth" in this context refers to compliance with established engineering and biocompatibility standards, not expert human interpretation for a diagnostic or AI device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, a MRMC study was not done. This device is a physical medical instrument, not an AI/ML diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No, not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• For physical devices, the "ground truth" is adherence to predefined engineering specifications, internationally recognized standards (ISO, ASTM, USP), and established safety and performance benchmarks (e.g., sterilization effectiveness, material strength, biocompatibility profiles). It's a truth based on physical and chemical properties and their interaction, rather than clinical outcomes or diagnostic interpretations.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that uses a "training set."

9. How the ground truth for the training set was established:

• Not applicable.

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The DORA Tubing Sets for Hemodialysis are single-use sterile medical devices intended to connect the patient to the hemodialyzer and the hemodialysis delivery system in hemodialysis treatment. The compatibility of available configurations is the responsibility of the physician/clinician in charge.

The proposed devices, DORA Tubing Sets for Hemodialysis, mainly consists of two tubes, which are arterial line with certain components in red and venous line with certain components in blue, as well as two accessories which are recirculate connector and drainage bag. They are available in five (5) models, following very similar design principles, and has some differences in dimensions and configurations. The proposed devices are provided in sterile condition, it is subject to e-beam sterilization prior to release to achieve a Sterility Assurance Level (SAL) of 10-6.

This document is a 510(k) premarket notification for DORA Tubing Sets for Hemodialysis. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Therefore, it does not contain the detailed information about acceptance criteria and study design for performance metrics that would typically be found in a clinical study report or a more comprehensive performance evaluation for an AI-powered medical device.

Based on the provided text, here's what can be extracted and what information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria for performance metrics in a table format, nor does it provide quantitative performance data like sensitivity, specificity, or accuracy. Instead, it refers to conformity with established international standards for medical devices.

2. Sample size used for the test set and the data provenance

This document describes non-clinical laboratory testing and does not involve patient data or a "test set" in the context of an AI/algorithm study. The testing was performed on the device itself. Therefore, information about sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable or provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This document does not involve AI or an algorithm requiring ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This document does not involve AI or an algorithm requiring ground truth adjudication.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

No such study was conducted or is mentioned in this document. The device is a physical medical device (tubing sets), not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. This is a physical medical device. The "ground truth" for its performance is adherence to established engineering and biocompatibility standards.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This device is not an AI/machine learning algorithm.

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